ModPG3 Neo-Infant ISO 81060-2:2018

NCT05976425 | Terminated Results

• 1 other identifier: 60106449
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Automated blood pressure cuff measurements taken by an "oscillometric device" is the standard in numerous medical settings today. Studies show that oscillometric devices using algorithms are more accurate and consistent than devices using other non-invasive measuring techniques, especially in critical cases. SureBP algorithm estimates BP during cuff inflation; the second, StepBP algorithm does so during deflation. The purpose of this study is to test the algorithms contained in the ModPG3 on Neonate and Infants subjects to determine if they meet the requirements of ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Compliance of the ModPG3 Blood Pressure (BP) Readings With ISO Requirements

  Data shall be analyzed according to the formulas called out in section 6.2.6 of ISO 81060-2:2018/Amd 1:2020.

  Day 1 (up to one hour)

Study Arms (1)

Blood Pressure Readings

EXPERIMENTAL

Using the data acquisition software provided, a reading for the subject will be started. The tool will automatically record the pre-invasive blood pressure readings, then take the NIBP measurement with the device under test, and it will follow up with a post invasive blood pressure reading.

Device: ModPG3 Investigational Device; Device: Invasive Reference Equipment

Interventions

ModPG3 Investigational Device DEVICE

* Connex Vital Sign Monitor with ModPG3 * Laptop * Data Collection Software * USB cable * Power strip * Welch Allyn FlexiPort Disposable Blood Pressure Cuffs

Blood Pressure Readings

Invasive Reference Equipment DEVICE

* Surveyor S12/S19 * Hill-Rom ICU Medical data collection cable DIR 60119852 * Hill-Rom Edwards data collection cable DIR 60119853

Blood Pressure Readings

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Meets the neonatal or infant (less than 3 years of age) subject population.
• The neonate and infant subjects will already have an indwelling intra-arterial line.
• Subject's legally authorized representative must consent for the subject to participate.
• Subject's legally authorized representative must be able to read, write, speak in English and/or Italian.
• Subject must have an arm circumference in the range of 3.3-15.0 cm.
• Subject must be able to have blood pressures taken on the upper extremity closest to the arterial line
• The subject has one upper arm that is free of indwelling catheters or IV lines, shunts, oximetry sensors, dressings, etc. for attachment of a NIBP cuff.

You may not qualify if:

• Lack of Informed consent.
• Subjects with deformities or abnormalities that may prevent proper application of the device under test.
• Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
• Subjects with known heart dysrhythmias or arrhythmias during the measurement period.
• Subjects with compromised circulation or peripheral vascular disease.
• Subjects who have had surgery or have shunts or implants in the upper extremity being tested.
• Those who have a heart rate that is irregular for any reason other than normal fluctuations in the R-to-R interval associated with respiration.
• Hospital System Pre-Screening NIBP: those who have a systolic and/or diastolic blood pressures difference \> 12 mmHg between the hospital intra-arterial measurement and the hospital blood pressure cuff/automated vital signs monitor are excluded. The device under test cannot be used for this reading.
• Subjects with clotting disorders or taking prescribed blood thinners.
• Subjects with a severe contact allergy to sensors or cuff material.
• Subjects with a history of skin fragility or breakdown, such as ecchymosis or lacerations, affecting the upper extremities that would affect the application of NIBP cuff.
• Subjects whose arm circumference does not fall within 3.3 and 15.0 cm.
• Arterial line is not properly damped.
• The subject has an unstable condition in which NIBP cannot be obtained.
• Subjects who have radial or brachial arterial lines.

Sponsors & Collaborators

• Welch Allyn: lead

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Limitations and Caveats

The study was terminated early due to errors in the StepBP and SureBP algorithms. Although raw data files were captured, no validated post processing algorithm was finalized; therefore, no analyzable blood pressure measurements exist. As a result, no outcome data are reported and no participants were analyzed.

Results Point of Contact

• Title: Baxter Clinical Trials Disclosure Call Center
• Organization: Baxter Healthcare

Global_CORP_ClinicalTrialsDisclosure@baxter.com

(224) 948-7359

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: February 23, 2024
• Primary Completion: April 29, 2025
• Study Completion: April 29, 2025
• Last Updated: February 23, 2026
• Results First Posted: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon approval of a legitimate research request.
• Access Criteria: Research requests will be reviewed by qualified medical and scientific experts within the company. If Baxter agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of Baxter prior to the release of any data.

Locations

US (1)